Contributed Commentary By Mika Lindroos & Sandra “SAM” Sather

December 27, 2016 | Is the integration of eConsent & eCOA the answer to supporting the adoption of electronic informed consent in clinical trials?

Securing informed consent from participants is a crucial requirement for all clinical trials. Informed consent is not only about obtaining a signature from a potential research subject, it is a complex process that involves many stakeholders in the development and recording. For this reason, it has to be dynamic. The participant must be able to withdraw their consent at any time during a trial, needs to be provided with a means to refer back to the information in the consent during their participation, and should be offered timely re-consent when study changes have occurred that may affect their decision to continue participation. Failing to support the proper consent of trial participants can have a major impact on regulatory compliance, enrollment and retention rates, and expenses across a study’s lifecycle.

As an industry, we have the responsibility to ensure that participants are consented in a way that supports that they truly comprehend the information needed to make a voluntary decision, along with the support of the investigator and appropriately delegated study site staff. Although sponsors must ensure that data collected is from consented subjects prior to study specific procedures, adequately obtaining informed consent remains a significant challenge for the industry and has not been well managed through traditional paper-based methods.

The introduction of electronic informed consent (eConsent) solutions to communicate study information, while supporting the management of informed consent processes, offers huge improvements to participant on-boarding in today’s clinical trials. eConsent creates a more patient-centric trial experience by including design elements such as video, text, and graphics to support the comprehension of information in a way that enables participants’ to make educated decisions. A relatively new entrant into an industry already known to be conservative in its integration of technology, eConsent has experienced slow adoption, perhaps due to a lack of established solutions offered, but also, we believe, due to eConsent potentially being seen by sponsors as one technology hurdle too many. With the increasing regulatory support for eConsent and growing industry interest in the benefits it offers, much of that is about to change.

Collecting consent via electronic methods offers numerous benefits to study participants, sponsors, ethics committees, and investigators. These include the capability to mitigate regulatory risks and provide a more efficient way of collecting consent, saving time and money in the long run. By combining tiered information delivery, interactive assessments, rich multi-media, and support for further communication with study staff, eConsent can help achieve better understanding of complex information and concepts. Verifying that patients comprehend consent information using interactive knowledge checks and soliciting questions about the study, may improve the quality of the retention and, as a result, may achieve better consent and protocol compliance, reducing costly dropouts.

Clearing Technology Hurdles

We believe sponsors face two main hurdles when looking to adopt an eConsent solution for their clinical trials. The first is the challenge of replacing previous paper-based consent processes with new electronic platforms, including how to go about incorporating the technology solution, as well as all the associated processes and requirements, into the design of their study. The second is ensuring the eConsent technology integrates with any existing platforms, such as eCOA or trial management solutions.

From the very beginning, sponsors need to consider all the various technologies that they will be using throughout the study program, including eConsent, and how those systems can work alongside or integrate with each other to achieve the best possible outcomes and efficiencies with minimum data quality risks.

The challenge of implementing this new approach can be lessened by implementing eConsent solutions that integrate with existing technology, such as the eCOA platforms already being used by many trials. By integrating informed consent and eCOA on a single platform and on the same device, the additional burden on study teams that would be inherent with the use of a separate system may be eliminated. This also provides considerable cost savings to sponsors by removing the need to purchase an additional system and provision additional devices, as well as the time and cost associated with integration procedures and training.

Navigating Regulatory Approval of eConsent

As with the introduction of any new technology, sponsors must ensure they are able to provide the regulatory authorities with the information needed to review and approve the process. With this in mind, sponsors should make sure they coordinate with the applicable ethics committees on how they will review the process.

IRBs/IECs have the ability to slow down the research and approval process significantly if they are not satisfied with the approach taken, so not engaging with the relevant stakeholders as early in the process as possible could prove pivotal to the success of an integrated eConsent solution, as well as the success of the overall trial. The integration of eCOA and eConsent can help facilitate ethics committee reviews through benchmarking the approach of communication with IRBs/IECs. That being said, identifying the additional considerations when adding eConsent will help in planning and anticipating IRB/IEC questions. Some examples of additional considerations might include: the collection of any protected health information, electronically linking the study subject’s identity with the system, and remote consenting using the subject’s own computer.

When possible, study sponsors should work with ethics committees that have experience with eConsent and which have developed standard operating procedures for projects that use eConsent. However, a global multi-center study is highly likely to involve regional ethics committees that are not experienced with eConsent. In this situation, the information gained from experienced IRBs should be shared. Partnering on study pilots integrating eConsent will be very beneficial for all stakeholders. In addition, be sure to use lessons learned from ethics committees’ electronic control requirements and review processes related to studies that include eCOA.

Final Thought

For sponsors who are finding themselves under increasing pressure to bring new treatments or procedures to market within shorter timeframes and increasingly tight budgets, the introduction of yet another new technology could be seen as too much to take on. However, eConsent can reduce the risk of informed consent noncompliance and negative audit findings through better management and documentation of the consent process. By integrating eConsent technology with existing platforms, sponsors can remove the need for any additional technologies to be included in a trial’s design, significantly reducing the complexity for study teams, and promoting participant compliance and retention by driving better comprehension of a study’s unique requirements.

In addition, while the perceived costs of integration could be seen by some as a barrier, we believe the potential to drive significant operational efficiencies, minimize regulatory risk, ensure participant comprehension, as well as achieve long-term cost savings, is clear. While the initial investment is likely higher than paper for most mid to large-scale studies, the right eConsent solution should save money over time because the system should get “smarter” related to the saved information and IRB familiarity with the content. Therefore, the return on investment (ROI) achieved using an eConsent solution has the potential to be very similar to the ROI achieved using eCOA, meaning that many types of trials will be less expensive than their paper-based counterparts. Additionally, there are significant cost savings to be achieved when solutions support decreased compliance issues that may require extra monitoring and data collection, leading to a lower total cost overall. However, and perhaps most importantly, what we hope to see proven as more trials adopt eConsent, is real value in the form of improved data quality and integrity of regulatory submissions.

Mika Lindroos is Director of Product Management at CRF Health. With just over two decades in software product management in the global environment, Mika’s breadth of experience spans from product and portfolio management, strategy and business development, and heading a product line at Nokia, to revenue and business relationship development at Digia. He can be reached at mika.lindroos@crfhealth.com

Sandra "SAM" Sather’s current focus of consulting is to promote clinical quality systems for Sponsors/CROs and Investigators/Research Institutions. She is a current member of the ACRP Academy Board of Trustees, and ACRP Regulatory Affairs Committee (RAC); SAM has been a clinical research coordinator, site manager, sponsor and CRO monitor, auditor, trainer and quality manager. In 2002 she co-founded Clinical Pathways (CP), LLC. She can be reached at samsather@clinicalpathwaysresearch.com